Mildly to moderately active ulcerative colitis
Conditions
Sponsors
MOCHIDA PHARMACEUTICAL CO., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Subjects who are diagnosed as ulcerative colitis (2)Subjects who are total score of 3-8 on the Ulcerative Colitis Disease Activity Index (UC-DAI) with a sigmoidoscopy score of 1 or higher, a rectal bleeding score of 1 or higher, and a Physician's Global Assessment (PGA) score of 2 or less at the baseline (3)Body weight 18-90 kg at the baseline etc
Exclusion criteria
Exclusion criteria: (1)Subjects with a history of colectomy (except appendectomy) (2)Subjects with moderate/severe renal or liver impairment (3)Subjects with serious blood disorder, respiratory disorder, digestive disorder, cardiovascular disorder, psychiatric disorder, abnormal electrolyte metabolism disorder or hypersensitivity as complication (4)Subjects with malignant tumor as complication etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Efficacy Clinical remission based on UC-DAI score Safety Adverse events Pharmacokinetics Plasma concentrations of 5-ASA and Ac-5-ASA at each evaluation visits | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy (1)Changes in UC-DAI scores (2)Remission defined by UC-DAI score (3)Endoscopic remission defined by UC-DAI score (4)Remission defined by PUCAI score etc Safety Adverse drug reaction | — |
Countries
Japan
Outcome results
None listed